MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY TUBE

Model Number 100/150/075

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that after induction of anesthesia and insertion of the endotracheal tube when attempting to deflate the cuff.The pilot tube disconnected from the tube.This was a very easy intubation with a videolaryngoscope sp the was no contact between the patient's teeth or the laryngoscope blade.There was no stretching of the pilot tube and it seemed that there was a disconnection due to failure at the point of insertion of the endotracheal tube pilot into the tube itself.No adverse patient effects were reported.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12310964
• MDR Text Key: 266152576
• Report Number: 3012307300-2021-08331
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/150/075
• Device Catalogue Number: 100/150/075
• Device Lot Number: 20031075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1